NA 8106132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207000755), received between Feb 1, 2019 and Feb 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION. USER FACILITY RETURNED THE DEVICE TO RWMIC ON (B)(6) 2018, AND THE EVALUATION WAS COMPLETED ON (B)(6) 2019. THE CABLE WAS INSPECTED AND THE CABLE WAS FOUND TO BE BROKEN. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE WEAR AND TEAR. THE CAUSE FOR THE WIRE BREAKAGE IS THE USE OF THE CABLE. UP TO THE ABSOLUTE WEAR/ FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8299055 ↗
• MalfunctionFeb 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION. USER FACILITY RETURNED THE DEVICE TO RWMIC ON (B)(6) 2018, AND THE EVALUATION WAS COMPLETED ON (B)(6) 2019. THE CABLE WAS INSPECTED AND THE CABLE WAS FOUND TO BE BROKEN. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE WEAR AND TEAR. THE CAUSE FOR THE WIRE BREAKAGE IS THE USE OF THE CABLE. UP TO THE ABSOLUTE WEAR/ FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8299054 ↗